MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....with characteristics unique to the design, will present challenges in developing.....distribution, crystallinity, dose content uniformity, microbial content, and stability..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

IND content and format for Phase 1 studies
...As clinical development of a drug product proceeds,sponsors should discuss the manufacturing.....Flow diagrams are suggested as the usual,most effective, presentations of this information.....and the general requirements for an IND's content and format. III. CLARIFICATIONS OF..
http://www.fda.gov/cder/guidance/phase1.pdf (score=46)

Guidance- Content & Format CMC for Vaccine & Related Product
...A description should be provided of the potency assay for the drug product.Information should be.....This guidance document represents FDA's current thinking on the content and format of the.....A list should be provided of all components in the drug product, including drug substance(s)and..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=40)

International Conference on Harmonisation: Public Meeting 1/17/2002 Transcript
...So it's dangerous to give examples but, you know, for drug product quality and drug product substance, we are working on.....Its full title is "Content and Format of CMC Information for Therapeutic Recombinant DNA-Derived Product or.....You could again use it up to 50 milligrams per day in a drug product, or at least that's the..
http://www.fda.gov/cder/audiences/iact/meeting_transcript_011702.htm (score=11)

Document
...lishment Description Information for a Vaccine or Related Product.. Content and Format of Chemistry, Manufacturing, and.....Reprocessing, Reworking, and Blending of Biological Drug Substances and Drug Prod- Stephen.....Drug Administration Modernization Act: Guidance on FDA's Transition Plan for Exist-ing..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15660.pdf (score=11)

Selected Guidance Documents Applicable to Combination Products
...Content of Investigational New Drug Applications for Phase I Studies of Drugs Including Well Characterized, Therapeutic.....Availability of Information Given to Advisory Committee Members in Connection with CDRH.....As an aid to sponsors seeking to develop a combination product, the Office of Combination..
http://www.fda.gov/oc/combination/guidance.html (score=9)

Guidance for Industry: Industry-Supported Scientific and Educational Activities
...of a drug or device while it is held for sale after.. umbrella of an overall regulatory.....include such additional information, protected speech, they are commercial.. Nevertheless.....that the company and provider agree to, the ultimate content of presentations is..
http://www.fda.gov/cber/gdlns/sciedu.pdf (score=7)

The New Food Label
...FDA requires nutrition information for foods about which health or nutrient-content claims.....If the product doesn't, and the differences materially limit the product's use, its label.....Under regulations from the Food and Drug Administration of the Department of Health and..
http://www.fda.gov/opacom/backgrounders/foodlabel/newlabel.html (score=4)

Las Vegas Injury Lawyer